ADXS11-001 High Dose HPV+ Cervical Cancer
This trial is active, not recruiting.
|Conditions||effects of immunotherapy, metastatic/recurrent cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, cervical small cell carcinoma, stage iii cervical cancer, stage iva cervical cancer, stage ivb cervical cancer|
|Phase||phase 1/phase 2|
|Start date||January 2015|
|End date||December 2018|
|Trial size||25 participants|
|Trial identifier||NCT02164461, Lm-LLO-E7-1401|
To evaluate the tolerability and safety of ADXS11-001 (1 x 10^10 colony forming units [cfu]) administered with prophylactic premedication in repeating 3-dose study cycles in women with persistent, metastatic, or recurrent squamous and non-squamous carcinoma, adenosquamous, or adenocarcinoma of the cervix. To evaluate tumor response and progression-free survival (PFS, time to progression) by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0
time frame: 12 weeks
Frequency and severity of adverse effects as assessed by CTCAE v 4.0
time frame: Up to 3 years
Changes in clinical immunology based upon serum
time frame: Baseline to up to 24 hours after dose 3
Proportion of patients who have objective tumor response (complete or partial)
time frame: Up to 3 years
Female participants at least 18 years old.
Inclusion Criteria: - Patients with histologically-confirmed, persistent, metastatic or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to surgery or standard radiotherapy). - Patients who have received no more than 1 prior cytotoxic treatment regimen. - Subject may have received ≤2 prior regimens for the treatment of their metastatic disease. - Subject is able to provide written informed consent. - Subject must have an ECOG performance status of 0 or 1. Exclusion Criteria: - In the opinion of the investigator, subject has rapidly progressing disease, OR has life expectancy of less than 6 months, OR would be unable to receive at least one cycle of therapy. - Subject has received chemotherapy and/or radiation therapy (except palliative radiation therapy for disease-related pain) within ≤2 weeks of first ADXS11-001 infusion. - Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. - Has a contraindication to administration of trimethoprim/sulfamethoxazole or ampicillin. - Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant.
|Official title||PHASE 1-2 STUDY EVALUATING HIGH DOSE ADXS11-001 (1 x 10^10 CFU) TREATMENT IN WOMEN WITH HPV+ CARCINOMA OF THE CERVIX|
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